SOLICITATION NOTICE
A -- NIAID PRECLINICAL DEVELOPMENT SUPPORT
- Notice Date
- 3/17/2015
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- RFP-NIAID-DAIDS-NIHAI2015035
- Archive Date
- 4/16/2015
- Point of Contact
- Kishan Patel, Phone: 240-669-5157, Michelle L Scala, Phone: 301-496-0612
- E-Mail Address
-
patelki@niaid.nih.gov, mscala@niaid.nih.gov
(patelki@niaid.nih.gov, mscala@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Primary Point of Contact Kishan Patel Contract Specialist patelki@niaid.nih.gov Phone: (240) 669-5157 Secondary Point of Contact Michelle L. Scala Contracting Officer mscala@niaid.nih.gov Phone: (240) 669-5156 Anticipated Period of Performance The anticipated period of performance is August 29, 2015 through August 28, 2016. Anticipated award date: August 29, 2015 The NAICS Code is 541712-Research and Development in the Physical, Engineering and Life Sciences- with a size standard of 500 employees. Introduction The National Institute of Allergy and Infectious Diseases (NIAID), is seeking a contractor to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. The development of vaccines and any other mucosally/systemically deliverable entities to prevent the spread of Human Immunodeficiency Virus (HIV) infection is among the NIAID's highest priorities. In addition, vaccines administered to infected individuals have potential for inducing immune control of the infectious agent. While advances in immunology and molecular biology continue to offer an expanding array of approaches for the development of new vaccines/products, there is limited capacity to move promising concepts through the development process. In order to supplement limited industry involvement in developing products, NIAID requires a nontraditional, proactive and developmentally-oriented program to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. NIAID will use this contract to more rapidly and efficiently close development and production gaps. These functions support the fundamental goals of the Vaccine Translational Research Branch (VTRB) under the Vaccine Research Program (VRP), Division of AIDS (DAIDS). Description The Division of AIDS currently supports a contract for NIAID HIV/AIDS for Preclinical Development Support under contract HHSN272201100021I with Advanced BioScience Laboratories, Inc. (ABL). The purpose of the contract is to provide preclinical development support for promising products when such candidates emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. The Contractor shall assist NIAID staff in providing all support needed for small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. Specifically, the Contractor manages a preclinical research program that identifies and develops potential HIV products by providing scientific, technical, and management expertise. The Contractor shall assist in identification, testing, and development of products; participate in and manage preclinical testing including in vitro laboratory testing, immunogenicity testing, efficacy studies, and toxicology testing using laboratory animals; and utilize GMP production protocols to produce promising products. Furthermore, the Contractor shall also maintain inventories of products, provide quality assurance and quality control, provide the appropriate regulatory documentation, and develop and manage a database that tracks the preclinical development of the products. The Contractor shall carry out, either directly or through subcontractors and/or consultants, tasks in the following areas: 1) Essential Core Activities that includes essential activities to be performed by the Contractor on a regular basis and consist of the following: (a) Project Management, (b) Quality Assurance/Quality Control, (c) Data Management, (d) Storage and Shipping, (e) Reporting Requirements/Deliverables, and (f) Transition; 2) Feasibility Assessments, that includes the assessment of products for feasibility of design, development, manufacture, potency assay development and stability for the development of phase I-III clinical trial materials; 3) Audits, that includes audit conduct, review and evaluation. Types of audits to be conducted include, but are not limited to technical and/or facilities audits. 4) Regulatory Documentation that includes development of a Master File, Investigator's Brochure, and compilation of an IND application, including a clinical trial protocol (provided by NIAID) appropriate for submission to the U.S. Food and Drug Administration (FDA). [Guidance on regulatory requirements can be obtained through the FDA Center for Biologics Evaluation and Research website (www.fda.gov/cber).] Regulatory documentation is required for products produced and/or tested for use in NIAID-sponsored research, in collaboration with the product supplier. 5) Process Development and current Good Manufacturing Practices (cGMP) Manufacture, that includes the production of vaccines and research-grade products as requested by the COR, including process development and production of cGMP pilot lots suitable for early phase human clinical trials, and performance of the necessary characterization tests required for release for clinical use; 6) Safety and Immunogenicity Testing, that includes the performance of pre-clinical testing of products as required for regulatory compliance prior to initial human clinical trial evaluation. The purpose of this follow-on extension is to continue to provide Preclinical Development Support for NIAID DAIDS HIV and AIDS research as described above. The NIAID intends to negotiate, under authority of FAR 6.302-1 and HHSAR 306.302-1, on a sole source basis, with ABL to increase the contract ceiling to support the current ongoing activities from August 29, 2015 through August 28, 2016. No other source is able to provide these critical/essential services beginning on August 29, 2015 without causing unacceptable delays to the Government in fulfilling the agency's requirements. This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement. All capability statements received within fifteen days from the date of the publication of this notice will be considered by the Government. A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. This proposed acquisition was previously advertised under a Research and Development Sources Sought Notice that was posted in the Federal Business Opportunities on January 9, 2015, as notice number HHS-NIH-NIAID-RDSS-NIHAI2015035.
- Web Link
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- Record
- SN03670941-W 20150319/150317235959-574dcb4005cf46f953ce8b297d9b9112 (fbodaily.com)
- Source
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